The following data is part of a premarket notification filed by Sgmp Co., Ltd. with the FDA for Vital Shield Gold Non-sterile Powdered Latex Exam Gloves Blue, With And/or Without Bubblegum Scent, And With Protein Lab.
| Device ID | K000488 |
| 510k Number | K000488 |
| Device Name: | VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB |
| Classification | Latex Patient Examination Glove |
| Applicant | SGMP CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker SGMP CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-14 |
| Decision Date | 2000-03-20 |